Re-evaluation of oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (E 479b) as a food additive

Maged Younes; Gabriele Aquilina; Laurence Castle; Karl-Heinz Engel; Paul Fowler; Maria Jose Frutos Fernandez; Peter Fürst; Rainer Gürtler; Ursula Gundert-Remy; Trine Husøy; Wim Mennes; Peter Moldeus; Agneta Oskarsson; Sandra Rainieri; Romina Shah; Dina Hendrika Waalkens-Berendsen; Detlef Wölfle; Polly Boon; Dominique Parent-Massin; Paul Tobback; Matthew Wright; Dimitrios Chrysafidis; Ana Maria Rincon; Alexandra Tard; Claude Lambré; EFSA Panel on Food Additives and Flavourings (FAF)

doi:10.2903/j.efsa.2018.5420

Re-evaluation of oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (E 479b) as a food additive

Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert-Remy, Trine Husøy, Wim Mennes, Peter Moldeus, Agneta Oskarsson, Sandra Rainieri, Romina Shah, Dina Hendrika Waalkens-Berendsen, Detlef Wölfle, Polly Boon, Dominique Parent-Massin, Paul TobbackMatthew Wright, Dimitrios Chrysafidis, Ana Maria Rincon, Alexandra Tard, Claude Lambré, EFSA Panel on Food Additives and Flavourings (FAF)

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Abstract

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was no reliable information regarding the absorption, distribution, metabolism, excretion (ADME) for TOSOM. No adverse effects have been detected in a limited subchronic toxicity study in pigs. The Panel identified a no observed adverse effect level (NOAEL) of 5,400, the highest dose tested, from a chronic and carcinogenicity study in rats. No genotoxicity data were available. No reliable studies for reproductive or developmental toxicity were available. From the chronic and carcinogenicity study, no lesions in reproductive organs were described and the lack of carcinogenic effect alleviated the concern for genotoxicity at the first site of contact. The Panel concluded that the available toxicological data were insufficient to support the current ADI, in particular, due to the lack of ADME data and absence of developmental toxicity studies TOSOM (E 479b) is only authorised in one food category and only one reported use level that equals the maximum permitted level was submitted. The estimated high (P95) exposure reached an upper value of 10.1 mg/kg bw per day for toddlers. When comparing the highest estimated exposure of 10 mg/kg bw per day in toddlers with the NOAEL of 5,400 mg/kg bw per day (the highest dose tested), the margin of safety (MoS) would be 540. Therefore, the Panel considered the use of TOSOM (E 479b) to be of no safety concern, in particular when considering the limited current use of this food additive. The Panel also recommended some modifications of the EU specifications for E 479b.

Original language	English
Pages	e05420
Number of pages	20
Volume	16
No.	10
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2018.5420
Publication status	Published - 10 Oct 2018

Bibliographical note

Acknowledgements: The Panel wishes to thank the Working Group on the re-evaluation of food additives other than gums and colours of the former EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) for the preparatory work on this scientific output, in particular Pasquale
Mosesso and Rudolf Antonius Woutersen. The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.

Keywords

thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids
TOSOM
E 479b
food additive

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© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalfof European Food Safety Authority.This is an open access article under the terms of the Creative Com mons Attribution-NoDerivs License,which permits use and distribution in any medium, provided the original work is properly cited and nomodications or adaptations are made. https://creativecommons.org/licenses/by-nd/4.0/
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Cite this

Younes, M., Aquilina, G., Castle, L., Engel, K.-H., Fowler, P., Frutos Fernandez, M. J., Fürst, P., Gürtler, R., Gundert-Remy, U., Husøy, T., Mennes, W., Moldeus, P., Oskarsson, A., Rainieri, S., Shah, R., Waalkens-Berendsen, D. H., Wölfle, D., Boon, P., Parent-Massin, D., ... EFSA Panel on Food Additives and Flavourings (FAF) (2018). Re-evaluation of oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (E 479b) as a food additive. EFSA Journal, 16(10), e05420. https://doi.org/10.2903/j.efsa.2018.5420

Younes, M, Aquilina, G, Castle, L, Engel, K-H, Fowler, P, Frutos Fernandez, MJ, Fürst, P, Gürtler, R, Gundert-Remy, U, Husøy, T, Mennes, W, Moldeus, P, Oskarsson, A, Rainieri, S, Shah, R, Waalkens-Berendsen, DH, Wölfle, D, Boon, P, Parent-Massin, D, Tobback, P, Wright, M, Chrysafidis, D, Rincon, AM, Tard, A, Lambré, C & EFSA Panel on Food Additives and Flavourings (FAF) 2018, 'Re-evaluation of oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (E 479b) as a food additive' EFSA Journal, vol. 16, no. 10, pp. e05420. https://doi.org/10.2903/j.efsa.2018.5420

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abstract = "The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was no reliable information regarding the absorption, distribution, metabolism, excretion (ADME) for TOSOM. No adverse effects have been detected in a limited subchronic toxicity study in pigs. The Panel identified a no observed adverse effect level (NOAEL) of 5,400, the highest dose tested, from a chronic and carcinogenicity study in rats. No genotoxicity data were available. No reliable studies for reproductive or developmental toxicity were available. From the chronic and carcinogenicity study, no lesions in reproductive organs were described and the lack of carcinogenic effect alleviated the concern for genotoxicity at the first site of contact. The Panel concluded that the available toxicological data were insufficient to support the current ADI, in particular, due to the lack of ADME data and absence of developmental toxicity studies TOSOM (E 479b) is only authorised in one food category and only one reported use level that equals the maximum permitted level was submitted. The estimated high (P95) exposure reached an upper value of 10.1 mg/kg bw per day for toddlers. When comparing the highest estimated exposure of 10 mg/kg bw per day in toddlers with the NOAEL of 5,400 mg/kg bw per day (the highest dose tested), the margin of safety (MoS) would be 540. Therefore, the Panel considered the use of TOSOM (E 479b) to be of no safety concern, in particular when considering the limited current use of this food additive. The Panel also recommended some modifications of the EU specifications for E 479b.",

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note = "Acknowledgements: The Panel wishes to thank the Working Group on the re-evaluation of food additives other than gums and colours of the former EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) for the preparatory work on this scientific output, in particular Pasquale Mosesso and Rudolf Antonius Woutersen. The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.",

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AU - Engel, Karl-Heinz

AU - Fowler, Paul

AU - Frutos Fernandez, Maria Jose

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AU - Gürtler, Rainer

AU - Gundert-Remy, Ursula

AU - Husøy, Trine

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AU - Lambré, Claude

AU - EFSA Panel on Food Additives and Flavourings (FAF)

N1 - Acknowledgements: The Panel wishes to thank the Working Group on the re-evaluation of food additives other than gums and colours of the former EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) for the preparatory work on this scientific output, in particular Pasquale Mosesso and Rudolf Antonius Woutersen. The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.

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N2 - The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was no reliable information regarding the absorption, distribution, metabolism, excretion (ADME) for TOSOM. No adverse effects have been detected in a limited subchronic toxicity study in pigs. The Panel identified a no observed adverse effect level (NOAEL) of 5,400, the highest dose tested, from a chronic and carcinogenicity study in rats. No genotoxicity data were available. No reliable studies for reproductive or developmental toxicity were available. From the chronic and carcinogenicity study, no lesions in reproductive organs were described and the lack of carcinogenic effect alleviated the concern for genotoxicity at the first site of contact. The Panel concluded that the available toxicological data were insufficient to support the current ADI, in particular, due to the lack of ADME data and absence of developmental toxicity studies TOSOM (E 479b) is only authorised in one food category and only one reported use level that equals the maximum permitted level was submitted. The estimated high (P95) exposure reached an upper value of 10.1 mg/kg bw per day for toddlers. When comparing the highest estimated exposure of 10 mg/kg bw per day in toddlers with the NOAEL of 5,400 mg/kg bw per day (the highest dose tested), the margin of safety (MoS) would be 540. Therefore, the Panel considered the use of TOSOM (E 479b) to be of no safety concern, in particular when considering the limited current use of this food additive. The Panel also recommended some modifications of the EU specifications for E 479b.

AB - The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was no reliable information regarding the absorption, distribution, metabolism, excretion (ADME) for TOSOM. No adverse effects have been detected in a limited subchronic toxicity study in pigs. The Panel identified a no observed adverse effect level (NOAEL) of 5,400, the highest dose tested, from a chronic and carcinogenicity study in rats. No genotoxicity data were available. No reliable studies for reproductive or developmental toxicity were available. From the chronic and carcinogenicity study, no lesions in reproductive organs were described and the lack of carcinogenic effect alleviated the concern for genotoxicity at the first site of contact. The Panel concluded that the available toxicological data were insufficient to support the current ADI, in particular, due to the lack of ADME data and absence of developmental toxicity studies TOSOM (E 479b) is only authorised in one food category and only one reported use level that equals the maximum permitted level was submitted. The estimated high (P95) exposure reached an upper value of 10.1 mg/kg bw per day for toddlers. When comparing the highest estimated exposure of 10 mg/kg bw per day in toddlers with the NOAEL of 5,400 mg/kg bw per day (the highest dose tested), the margin of safety (MoS) would be 540. Therefore, the Panel considered the use of TOSOM (E 479b) to be of no safety concern, in particular when considering the limited current use of this food additive. The Panel also recommended some modifications of the EU specifications for E 479b.

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